This instrument is intended for the percent determination of hemoglobin A1c (HbA1c) in human whole blood.

Working Principles

HbA1c Analyzer uses the (borate affinity) fluorescent immunoturbidimetry. Push a mixture containing a fluorescent borate conjugate into an integrated test cup and mix to dissolve sufficiently. The blood samples in the sample collector are then pushed into the buffer and mixed to release the hemoglobin from the red blood cells. The total concentration of hemoglobin depends on the initial reduced fluorescence signal. Fluorescent borate conjugates bind to glycosylated hemoglobin, and glycosylated hemoglobin is determined by detecting the decrease of fluorescent active ingredients. The percentage of glycosylated hemoglobin in total hemoglobin can be determined.

Basic Parameters

Blood collection volume: The sampling volume of whole blood should not be less than 4μl.

Sample volume: 4μl full blood.

Analytical wave length: 510nm and 580 nm.

Performance Indicators

⇔Result reporting unit

Glycated hemoglobin (HbA1c) is reported by default in IFCC units (mmol/mol) and NGSP units (%).

⇔Appearance

The appearance of the analyzer shall meet the following requirements:

a) The appearance of the instrument is neat and clean, and there is no obvious peeling, abrasion,

disbonded coating and dirt on the surface coating;

b) The nameplate and logo should be clear. All fasteners should not be loosened. Various adjusting

elements can rotate flexibl y and function normally.

c) Readouts should be clear on the display screen.

⇔Accuracy

The accuracy is tested with the reference material as samples, and the relative deviation of the determination results of the analyzer should be within the range of ±8%

⇔Precision

Samples with a concentration of 4.0%-6.5% are detected, and the sample coefficient of variation (CV) of the test results is not more than 3%.

⇔Linearity

In the range of 4%-16% of HbA1c, the linear correlation coefficient r of the tes t results should be no less than 0.9900.

⇔Stability

Within 8 hours after the instrument is turned on and stable, the same normal sample is tested, and the relative deviation of the test results is not more than ±3%.